The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the Ultrasound vs Mammography: a Clinical Noninferiority Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,277
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years and over with full capacity for civil conduct;
- •Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy;
- •Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
- •The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
- •It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).
排除标准
- •Women are participating in another clinical trial of drug or medical device;
- •Women with neuropsychiatric disorders;
- •Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial;
- •Other subjects not suitable for X-ray examination
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3 years
The time that the patient is free of the signs and symptoms of a disease after treatment.
Sensitive
时间窗: 3 days
Proportion of corrected-detected malignant lesions by the US or MG
Specificity
时间窗: 3 days
Proportion of corrected-detected benign lesions by the US or MG
Area under curve
时间窗: 3 days
Area under receiver operating characteristic (ROC) curve in percentage (%)
次要结局
未报告次要终点
研究者
Song Hongping
Principal Investigator
The First Affiliated Hospital of the Fourth Military Medical University